ObesityNCT00880958
Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity
A study testing Mixture of various probiotics and fermentation products in people with Obesity, run by Hiroshima University at 1 site in Japan.
Trial summary
The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Mixture of various probiotics and fermentation products
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy as based on medical history and physical examination
- BMI between 25 and 30 kg/m2
- Willing not to serve as blood donor during the study
- Informed consent signed
Who cannot join
- Food allergy
- Female subjects who are pregnant or nursing a child
- Participation in any clinical trial up to 90 days before Day 01 of this study
- Renal or hepatic dysfunction
- Heart disease
- Under medication
- Subjects who are taking functional food designed for weight loss or serum lipid reduction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial
The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.
- Conditions
- Obesity
- Being tested
- Mixture of various probiotics and fermentation products, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of various probiotics and fermentation productsDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Mixture of various probiotics and fermentation products |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: 16 weeks
Secondary outcomes (7)
Body fat mass
Measured: Week -4, Week 0, Week 4, Week 12
Abdominal circumference
Measured: Week -4, Week 0, Week 4, Week 12
Visceral fat area by CT scan
Measured: Week 0, Week 12
Intestinal flora
Measured: Week 0, Week 12
Serum lipid profile
Measured: Week -4, Week 0, Week 4, Week 12
Serum adiponectin and leptin levels
Measured: Week 0, Week 12
Fasting serum glucose and HbA1c levels
Measured: Week -4, Week 0, Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startMar 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- Biostir, Inc., MIONA Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880958
- Sponsor's protocol ID
- eki-123
- Status last verified
- Oct 2009
- First submitted
- 13 Apr 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00880958
- Acronym / sponsor ID
- eki-123
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- Biostir, Inc., MIONA Co., Ltd.
- Study start
- Mar 2009
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Mixture of various probiotics and fermentation products |
| 2 | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy as based on medical history and physical examination
- BMI between 25 and 30 kg/m2
- Willing not to serve as blood donor during the study
- Informed consent signed
Key exclusion criteria (7 listed)
- Food allergy
- Female subjects who are pregnant or nursing a child
- Participation in any clinical trial up to 90 days before Day 01 of this study
- Renal or hepatic dysfunction
- Heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixture of various probiotics and fermentation products | Dietary supplement | 1 |
| Placebo | Dietary supplement | 2 |
Primary outcome
Body mass index
Time frame: 16 weeks
7 secondary outcomes
Body fat mass
Time frame: Week -4, Week 0, Week 4, Week 12
Abdominal circumference
Time frame: Week -4, Week 0, Week 4, Week 12
Visceral fat area by CT scan
Time frame: Week 0, Week 12
Intestinal flora
Time frame: Week 0, Week 12
Serum lipid profile
Time frame: Week -4, Week 0, Week 4, Week 12
Serum adiponectin and leptin levels
Time frame: Week 0, Week 12
Fasting serum glucose and HbA1c levels
Time frame: Week -4, Week 0, Week 4, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixture of various probiotics and fermentation products in people with Obesity, run by Hiroshima University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2009.